Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT03447769
Status:
TERMINATED
Last Update Posted:
2024-10-09
First Post:
2018-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A
Sponsor:
Organization:
Raw JSON
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However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years.', 'description': 'Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants - Pre-treatment', 'description': "Deaths collected in the pre-treatment period (from day of patient's informed consent to the day before first administration of study treatment)", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 1382, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Canakinumab - On-treatment', 'description': 'AEs collected during on-treatment period (up to 130 days post-treatment)', 'otherNumAtRisk': 692, 'deathsNumAtRisk': 692, 'otherNumAffected': 465, 'seriousNumAtRisk': 692, 'deathsNumAffected': 9, 'seriousNumAffected': 141}, {'id': 'EG002', 'title': 'Canakinumab - Post-treatment Follow-up', 'description': 'Deaths collected in the post-treatment follow-up period (starting from day 131 post- treatment). No AEs were collected during this period', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 671, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 53, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo - On-treatment', 'description': 'AEs collected during on-treatment period (up to 130 days post-treatment)', 'otherNumAtRisk': 689, 'deathsNumAtRisk': 689, 'otherNumAffected': 455, 'seriousNumAtRisk': 689, 'deathsNumAffected': 17, 'seriousNumAffected': 146}, {'id': 'EG004', 'title': 'Placebo - Post-treatment Follow-up', 'description': 'Deaths collected in the post-treatment follow-up period (starting from day 131 post-treatment). No AEs were collected during this period', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 662, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 51, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 50}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 48}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 51}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 60}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 43}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 49}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 51}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 37}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 47}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 48}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 88}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 56}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 60}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 44}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 89}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 108}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 50}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 34}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 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'numAtRisk': 692, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pericarditis constrictive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 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'EG004', 'numAtRisk': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Renal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Bronchial obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Vocal cord polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0}, {'groupId': 'EG001', 'numAtRisk': 692, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 689, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease Free Survival (DFS) by Local Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '35.02', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '28.55', 'upperLimit': 'NA'}, {'value': '29.73', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '23.72', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.258', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.14', 'pValueComment': '1-sided p-value', 'estimateComment': 'The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 4 years', 'description': 'DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence.\n\nThe median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) including all participants to whom study treatment was assigned by randomization'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '51.12', 'comment': 'NA = Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '46.95', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 4.3 years', 'description': 'Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS including all participants to whom study treatment was assigned by randomization'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) in PD-L1 Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'title': 'PD-L1 <1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'PD-L1 ≥1% and <49%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.95', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '22.11', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'PD-L1 ≥50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.12', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 4.3 years', 'description': 'Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier curves, medians and 95% confidence intervals of the medians were presented for each treatment group. OS analysis was performed by programmed cell death-ligand 1 (PD-L1) expression status: PD-L1 \\<1%, PD-L1 ≥1% and \\<49%, and PD-L1 ≥50%.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants to whom study treatment was assigned by randomization with a valid baseline measurement of PD-L1 expression.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) in CD8 Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}, {'value': '449', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'title': 'CD8 < median', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.95', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '32.23', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'CD8 ≥ median', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.12', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to approximately 4.3 years', 'description': 'Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group. OS analysis was performed by CD8 subgroups with the median of baseline CD8 expression as cut-off.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants to whom study treatment was assigned by randomization with a valid baseline measurement of CD8 expression'}, {'type': 'SECONDARY', 'title': 'Lung Cancer Specific Survival (LCSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '51.12', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '44.71', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 4.3 years', 'description': 'LCSS is defined as the time from date of randomization to the date of death due to lung cancer. The LCSS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS including all participants to whom study treatment was assigned by randomization'}, {'type': 'SECONDARY', 'title': 'Disease Free Survival (DFS) by Local Investigator in PD-L1 Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'title': 'PD-L1 <1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.72', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '23.52', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '23.03', 'upperLimit': 'NA'}]}]}, {'title': 'PD-L1 ≥1% and <49%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.42', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '21.42', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '17.05', 'upperLimit': 'NA'}]}]}, {'title': 'PD-L1 ≥50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.95', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '19.45', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '22.31', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.676', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.58', 'pValueComment': '1-sided p-value', 'estimateComment': 'The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test', 'groupDescription': 'PD-L1 \\<1%', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.05', 'pValueComment': '1-sided p-value', 'estimateComment': 'The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test', 'groupDescription': 'PD-L1 ≥1% and \\<49%', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.823', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.73', 'ciUpperLimit': '2.43', 'pValueComment': '1-sided p-value', 'estimateComment': 'The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test', 'groupDescription': 'PD-L1 ≥50%', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 4 years', 'description': 'DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence.\n\nThe median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.\n\nDFS analysis was performed by baseline programmed cell death-ligand 1 (PD-L1) expression status: PD-L1 \\<1%, PD-L1 ≥1% and \\<49%, and PD-L1 ≥50%.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants to whom study treatment was assigned by randomization with a valid baseline measurement of PD-L1 expression.'}, {'type': 'SECONDARY', 'title': 'Disease Free Survival (DFS) by Local Investigator in CD8 Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}, {'value': '449', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'title': 'CD8 < median', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.58', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '20.67', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '25.03', 'upperLimit': 'NA'}]}]}, {'title': 'CD8 ≥ median', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.95', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '28.81', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '23.89', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.872', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.72', 'pValueComment': '1-sided p-value', 'estimateComment': 'The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.', 'groupDescription': 'CD8 \\< median', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.303', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.33', 'pValueComment': '1-sided p-value', 'estimateComment': 'The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.', 'groupDescription': 'CD8 ≥ median', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 4 years', 'description': 'DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence.\n\nThe median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.\n\nDFS analysis was performed by CD8 subgroups with the median of baseline CD8 expression as cut-off.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants to whom study treatment was assigned by randomization with a valid baseline measurement of CD8 expression'}, {'type': 'SECONDARY', 'title': 'Canakinumab Serum Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '664', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '664', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.1', 'spread': '6.53', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.9', 'spread': '5.43', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '636', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.0', 'spread': '4.91', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.7', 'spread': '10.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '559', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.7', 'spread': '13.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '530', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.1', 'spread': '14.5', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.6', 'spread': '15.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 on day 1 (pre-dose), day 8 and 15; Cycle 2, 4, 6, 9 and 12 on day 1 (pre-dose). Cycle=21 days', 'description': 'Serum concentrations of canakinumab were determinded using an ELISA method.', 'unitOfMeasure': 'ug/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic analysis set (PAS) including all subjects who received at least one dose of canakinumab and provided at least one evaluable PK sample.'}, {'type': 'SECONDARY', 'title': 'Canakinumab Anti-drug Antibody (ADA) Prevalence at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Canakinumab ADA prevalence at baseline was calculated as the percentage of participants who had an ADA positive result at baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of canakinumab'}, {'type': 'SECONDARY', 'title': 'Canakinumab ADA Incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to 130 days after end of treatment, assessed up to approx. 1.5 years', 'description': 'Canakinumab ADA incidence on-treatment was calculated as the percentage of participants who were treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that was at least the fold titer change greater than the ADA-positive baseline titer)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of canakinumab'}, {'type': 'SECONDARY', 'title': 'Time to Definitive 10 Point Deterioration Symptom Scores of Pain,Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '35.45', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '35.06', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '34.99', 'upperLimit': 'NA'}]}]}, {'title': 'Dyspnea', 'categories': [{'measurements': [{'value': '28.88', 'groupId': 'OG000', 'lowerLimit': '23.10', 'upperLimit': '34.96'}, {'value': '34.99', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '23.13', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline up to approximately 4 years', 'description': "The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms.\n\nThe time to definitive 10 point deterioration symptom scores of pain, cough and dyspnea was defined as the time from the date of randomization to the date of event, which was defined as at least 10 points relative to baseline worsening of the EORTC QLQ-LC13 symptom score with no later change below this threshold or death due to any cause, whichever occurred earlier.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS including all participants to whom study treatment was assigned by randomization'}, {'type': 'SECONDARY', 'title': 'Time to Definitive 10 Point Deterioration of Global Health Status/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'title': 'Global health status/QoL', 'categories': [{'measurements': [{'value': '34.99', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '29.93', 'upperLimit': 'NA'}, {'value': '35.15', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '35.15', 'upperLimit': 'NA'}]}]}, {'title': 'Shortness of breath', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '35.15', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '34.99', 'upperLimit': 'NA'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '29.93', 'groupId': 'OG000', 'lowerLimit': '28.29', 'upperLimit': '35.22'}, {'value': '36.44', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '34.99', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline up to approximately 4 years', 'description': 'The EORTC QLQ-C30 was a questionnaire developed to assess the health-related quality of life of cancer participants. It assessed 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores ranged from 0 to 100. A high score for the functional or global health status scales indicated a high level of functioning or QoL; a high score for a symptom scale indicated a high level of symptoms.\n\nThe time to definitive 10 point deterioration of global health status/QoL, shortness of breath and pain was defined as the time from the date of randomization to the date of event, which was defined as at least 10 points relative to baseline worsening of the EORTC QLQ-C30 score with no later change below this threshold or death due to any cause, whichever occured earlier.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS including all participants to whom study treatment was assigned by randomization'}, {'type': 'SECONDARY', 'title': 'Time to First 10 Point Deterioration for Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '35.15', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '26.58', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '23.06', 'upperLimit': 'NA'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '15.44', 'groupId': 'OG000', 'lowerLimit': '10.38', 'upperLimit': '23.06'}, {'value': '15.01', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '9.69', 'upperLimit': 'NA'}]}]}, {'title': 'Dyspnea', 'categories': [{'measurements': [{'value': '4.17', 'groupId': 'OG000', 'lowerLimit': '3.42', 'upperLimit': '5.55'}, {'value': '4.86', 'groupId': 'OG001', 'lowerLimit': '3.48', 'upperLimit': '6.97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline up to approximately 4 years', 'description': "The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms.\n\nThe time to first 10 point deterioration symptom scores of pain, cough and dyspnea was defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurred earlier.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS including all participants to whom study treatment was assigned by randomization'}, {'type': 'SECONDARY', 'title': 'Time to First 10 Point Deterioration of Global Health Status/QoL, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'title': 'Global health status/QoL', 'categories': [{'measurements': [{'value': '9.23', 'groupId': 'OG000', 'lowerLimit': '7.10', 'upperLimit': '11.76'}, {'value': '9.07', 'groupId': 'OG001', 'lowerLimit': '7.62', 'upperLimit': '11.76'}]}]}, {'title': 'Shortness of breath', 'categories': [{'measurements': [{'value': '29.14', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '23.03', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA: Not estimable due to the insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '23.13', 'upperLimit': 'NA'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '5.49', 'groupId': 'OG000', 'lowerLimit': '4.21', 'upperLimit': '6.90'}, {'value': '5.62', 'groupId': 'OG001', 'lowerLimit': '4.17', 'upperLimit': '7.62'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline up to approximately 4 years', 'description': 'The EORTC QLQ-C30 was a questionnaire developed to assess the health-related quality of life of cancer participants. It assessed 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores ranged from 0 to 100. A high score for the functional or global health status scales indicated a high level of functioning or QoL; a high score for a symptom scale indicated a high level of symptoms.\n\nThe time to first 10 point deterioration of global health status/QoL, shortness of breath and pain scores was defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurred earlier.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS including all participants to whom study treatment was assigned by randomization'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}, {'value': '629', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '626', 'groupId': 'OG000'}, {'value': '614', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}, {'value': '603', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}, {'value': '604', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '581', 'groupId': 'OG000'}, {'value': '572', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '564', 'groupId': 'OG000'}, {'value': '558', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '555', 'groupId': 'OG000'}, {'value': '556', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}, {'value': '550', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '528', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '523', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '461', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '452', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '440', 'groupId': 'OG000'}, {'value': '428', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '-0.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000'}, {'value': '-0.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 63', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 69', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Safety FU 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Safety FU 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Safety FU 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Safety FU 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Safety FU 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Efficacy FU 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Efficacy FU 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Efficacy FU 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Efficacy FU 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Efficacy FU 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': '7 days post disease progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': '28 days post disease progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, every 3 weeks for 14 months; end of treatment; every 4 weeks up to 130 days post-treatment; at 18,24,30,36 and 48 months post-randomization (if no recurrence); 7 and 28 days post-disease progression, up to approx. 4 years.', 'description': 'EQ-5D-5L was a standardized questionnaire that measured health-related QoL. EQ-5D-5L consisted of 2 components: a health state profile and a visual analogue scale. The health state profile included five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels ranging from 1 (no problems) to 5 (extreme problems).\n\nThe EQ-5D-5L health state profile responses were converted into single index utility score, ranging from -1 to 1, where lower scores representing a higher level of dysfunction. Published weights are available enabling the calculation of the utility score. A positive change from baseline indicated improvement. This endpoint was assessed throughout the study, including safety and efficacy follow-up (FU) visits. Safety FU visits: every 4 weeks after end of treatment up to 130 days post-last dose. Efficacy FU visits: at 18, 24, 30, 36 and 48 months post-randomization (if no recurrence observed during treatment or safety FU)', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants to whom study treatment was assigned by randomization with data available at the specified time points. Number analyzed refers to the number of participants with an evaluable value at the specified time point.'}, {'type': 'POST_HOC', 'title': 'All Collected Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'classes': [{'title': 'Pre-treatment deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'On-treatment deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '692', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment follow-up deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '671', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'All deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '689', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-treatment: Up to 28 days prior to treatment. On-treatment: Up to approx. 1.5 years. Post-treatment follow-up: Up to approx. 4.3 years', 'description': "Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication.\n\nOn-treatment deaths were collected from start of treatment to 130 days after last dose.\n\nPost-treatment follow-up deaths were collected from day 131 after last dose of study treatment to end of study.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS including all participants to whom study treatment was assigned by randomization'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '693'}, {'groupId': 'FG001', 'numSubjects': '689'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '692'}, {'groupId': 'FG001', 'numSubjects': '689'}]}, {'type': 'COMPLETED', 'comment': 'Participants who completed treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '414'}, {'groupId': 'FG001', 'numSubjects': '420'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '279'}, {'groupId': 'FG001', 'numSubjects': '269'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '148'}]}, {'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'The study was conducted across 290 centers in 41 countries. A total of 1830 subjects were screened of which 1382 participants were randomized to treatment on a 1:1 basis.', 'preAssignmentDetails': '1 participant randomized in the canakinumab arm was never treated due to subject decision.\n\nThe numbers in the patient disposition table correspond to the treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'BG000'}, {'value': '689', 'groupId': 'BG001'}, {'value': '1382', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Canakinumab', 'description': 'Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '8.90', 'groupId': 'BG000'}, {'value': '61.6', 'spread': '9.00', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '8.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '520', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '430', 'groupId': 'BG000'}, {'value': '432', 'groupId': 'BG001'}, {'value': '862', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '393', 'groupId': 'BG000'}, {'value': '391', 'groupId': 'BG001'}, {'value': '784', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '248', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Multiple', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-03', 'size': 6709442, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-27T04:39', 'hasProtocol': True}, {'date': '2023-03-03', 'size': 1725958, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-27T04:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1382}}, 'statusModule': {'whyStopped': 'Upon review of the primary analysis results, the benefit-risk was assessed by the Steering Committee Members with the decision that the study will be closed. No new safety signals were observed for canakinumab.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'dispFirstSubmitDate': '2023-02-28', 'completionDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2018-02-19', 'resultsFirstSubmitDate': '2023-12-27', 'studyFirstSubmitQcDate': '2018-02-21', 'dispFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-25', 'studyFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Free Survival (DFS) by Local Investigator', 'timeFrame': 'Up to approximately 4 years', 'description': 'DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence.\n\nThe median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 4.3 years', 'description': 'Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group.'}, {'measure': 'Overall Survival (OS) in PD-L1 Subgroups', 'timeFrame': 'Up to approximately 4.3 years', 'description': 'Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier curves, medians and 95% confidence intervals of the medians were presented for each treatment group. OS analysis was performed by programmed cell death-ligand 1 (PD-L1) expression status: PD-L1 \\<1%, PD-L1 ≥1% and \\<49%, and PD-L1 ≥50%.'}, {'measure': 'Overall Survival (OS) in CD8 Subgroups', 'timeFrame': 'up to approximately 4.3 years', 'description': 'Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group. OS analysis was performed by CD8 subgroups with the median of baseline CD8 expression as cut-off.'}, {'measure': 'Lung Cancer Specific Survival (LCSS)', 'timeFrame': 'Up to approximately 4.3 years', 'description': 'LCSS is defined as the time from date of randomization to the date of death due to lung cancer. The LCSS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group.'}, {'measure': 'Disease Free Survival (DFS) by Local Investigator in PD-L1 Subgroups', 'timeFrame': 'Up to approximately 4 years', 'description': 'DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence.\n\nThe median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.\n\nDFS analysis was performed by baseline programmed cell death-ligand 1 (PD-L1) expression status: PD-L1 \\<1%, PD-L1 ≥1% and \\<49%, and PD-L1 ≥50%.'}, {'measure': 'Disease Free Survival (DFS) by Local Investigator in CD8 Subgroups', 'timeFrame': 'Up to approximately 4 years', 'description': 'DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence.\n\nThe median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.\n\nDFS analysis was performed by CD8 subgroups with the median of baseline CD8 expression as cut-off.'}, {'measure': 'Canakinumab Serum Concentrations', 'timeFrame': 'Cycle 1 on day 1 (pre-dose), day 8 and 15; Cycle 2, 4, 6, 9 and 12 on day 1 (pre-dose). Cycle=21 days', 'description': 'Serum concentrations of canakinumab were determinded using an ELISA method.'}, {'measure': 'Canakinumab Anti-drug Antibody (ADA) Prevalence at Baseline', 'timeFrame': 'Baseline', 'description': 'Canakinumab ADA prevalence at baseline was calculated as the percentage of participants who had an ADA positive result at baseline'}, {'measure': 'Canakinumab ADA Incidence', 'timeFrame': 'From baseline up to 130 days after end of treatment, assessed up to approx. 1.5 years', 'description': 'Canakinumab ADA incidence on-treatment was calculated as the percentage of participants who were treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that was at least the fold titer change greater than the ADA-positive baseline titer)'}, {'measure': 'Time to Definitive 10 Point Deterioration Symptom Scores of Pain,Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire', 'timeFrame': 'From baseline up to approximately 4 years', 'description': "The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms.\n\nThe time to definitive 10 point deterioration symptom scores of pain, cough and dyspnea was defined as the time from the date of randomization to the date of event, which was defined as at least 10 points relative to baseline worsening of the EORTC QLQ-LC13 symptom score with no later change below this threshold or death due to any cause, whichever occurred earlier."}, {'measure': 'Time to Definitive 10 Point Deterioration of Global Health Status/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire', 'timeFrame': 'From baseline up to approximately 4 years', 'description': 'The EORTC QLQ-C30 was a questionnaire developed to assess the health-related quality of life of cancer participants. It assessed 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores ranged from 0 to 100. A high score for the functional or global health status scales indicated a high level of functioning or QoL; a high score for a symptom scale indicated a high level of symptoms.\n\nThe time to definitive 10 point deterioration of global health status/QoL, shortness of breath and pain was defined as the time from the date of randomization to the date of event, which was defined as at least 10 points relative to baseline worsening of the EORTC QLQ-C30 score with no later change below this threshold or death due to any cause, whichever occured earlier.'}, {'measure': 'Time to First 10 Point Deterioration for Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire', 'timeFrame': 'From baseline up to approximately 4 years', 'description': "The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms.\n\nThe time to first 10 point deterioration symptom scores of pain, cough and dyspnea was defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurred earlier."}, {'measure': 'Time to First 10 Point Deterioration of Global Health Status/QoL, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire', 'timeFrame': 'From baseline up to approximately 4 years', 'description': 'The EORTC QLQ-C30 was a questionnaire developed to assess the health-related quality of life of cancer participants. It assessed 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores ranged from 0 to 100. A high score for the functional or global health status scales indicated a high level of functioning or QoL; a high score for a symptom scale indicated a high level of symptoms.\n\nThe time to first 10 point deterioration of global health status/QoL, shortness of breath and pain scores was defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurred earlier.'}, {'measure': 'Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L)', 'timeFrame': 'Baseline, every 3 weeks for 14 months; end of treatment; every 4 weeks up to 130 days post-treatment; at 18,24,30,36 and 48 months post-randomization (if no recurrence); 7 and 28 days post-disease progression, up to approx. 4 years.', 'description': 'EQ-5D-5L was a standardized questionnaire that measured health-related QoL. EQ-5D-5L consisted of 2 components: a health state profile and a visual analogue scale. The health state profile included five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels ranging from 1 (no problems) to 5 (extreme problems).\n\nThe EQ-5D-5L health state profile responses were converted into single index utility score, ranging from -1 to 1, where lower scores representing a higher level of dysfunction. Published weights are available enabling the calculation of the utility score. A positive change from baseline indicated improvement. This endpoint was assessed throughout the study, including safety and efficacy follow-up (FU) visits. Safety FU visits: every 4 weeks after end of treatment up to 130 days post-last dose. Efficacy FU visits: at 18, 24, 30, 36 and 48 months post-randomization (if no recurrence observed during treatment or safety FU)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Small Cell Lung Cancer', 'NSCLC', 'ACZ885', 'canakinumab', 'adjuvant', 'AJCC/UICC v. 8 stages II-IIIA and IIIB (T>5cm N2)'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '37788412', 'type': 'DERIVED', 'citation': 'Garon EB, Lu S, Goto Y, De Marchi P, Paz-Ares L, Spigel DR, Thomas M, Yang JC, Ardizzoni A, Barlesi F, Orlov S, Yoshioka H, Mountzios G, Khanna S, Bossen C, Carbini M, Turri S, Myers A, Cho BC. Canakinumab as Adjuvant Therapy in Patients With Completely Resected Non-Small-Cell Lung Cancer: Results From the CANOPY-A Double-Blind, Randomized Clinical Trial. J Clin Oncol. 2024 Jan 10;42(2):180-191. doi: 10.1200/JCO.23.00910. Epub 2023 Oct 3.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1875', 'label': 'A Plain Language Trial Summary is available on www.novctrd.com'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study was to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages II -IIIA according to the 8th edition of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) and the subset of IIIB (T\\>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).', 'detailedDescription': 'This was a phase III, multicenter, randomized, double-blind study to evaluate the efficacy and safety of canakinumab as adjuvant therapy in adult patients with stages AJCC/UICC v.8 II-IIIA and IIIB (T\\>5 cm N2) completely resected (R0) NSCLC.\n\nApproximately 1500 patients were planned to be randomized 1:1 to canakinumab, 200 mg subcutaneously (s.c.) every 3 weeks or matching placebo s.c. every 3 weeks. Patients were planned to continue their assigned treatment until they completed 18 cycles (cycle= 21 days) or experienced any one of the following: non-small cell lung cancer (NSCLC) disease recurrence as determined by Investigator; unacceptable toxicity that precluded further treatment; treatment discontinuation at the discretion of the Investigator or patient; start of a new antineoplastic therapy; death, or loss to follow-up, whichever occurred first. All patients who discontinued from the study treatment were to be followed up every 12 weeks for survival until the final OS analysis or death, loss to follow-up or withdrawal of consent for survival follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Had completely resected (R0) NSCLC AJCC/UICC v. 8 stage IIA-IIIA and IIIB (N2 disease only) OR had NSCLC Stage IIA-IIIA, IIIB (N2 disease only) and were candidates for complete resection surgery.\n* Cisplatin-based chemotherapy was mandatory for all subjects (Exception: In subjects with stage IIA disease with no nodal involvement, cisplatin-based chemotherapy could be administered if recommended by the treating physician). When required, a minimum of two cycles of cisplatin-based chemotherapy was mandatory, after which additional therapies could be given based upon local clinical practice and/or guidelines. Typically, chemotherapy was initiated within 60 days of surgery.\n* Radiation therapy was allowed if indicated as per local guidelines or practice.\n* Had recovered from all toxicities related to prior systemic therapy to grade ≤ 1 (CTCAE v 5.0). Exception to this criterion: subjects with any grade of alopecia and grade 2 or less neuropathy were allowed to enter the study\n* Had ECOG performance status (PS) of 0 or 1\n\nKey Exclusion Criteria:\n\n* Had unresectable or metastatic disease, positive microscopic margins on the pathology report, and/or gross disease remaining at the time of surgery\n* Had received any neoadjuvant therapy\n* Had presence or history of a malignant disease, other than the resected NSCLC, that had been diagnosed and/or required therapy within the past 3 years Exceptions to this exclusion included the following: completely resected basal cell and squamous cell skin cancers, completely resected carcinoma in situ of any type and hormonal maintenance for breast and prostate cancer \\> 3 years.\n* Had a history of current diagnosis of cardiac disease\n* Had uncontrolled diabetes\n* Had known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results)\n* Subjects had to be evaluated for tuberculosis as per local treatment guidelines or clinical practice. Subjects with active tuberculosis were not eligible.\n* Had suspected or proven immunocompromised state as described in the protocol\n* Had live and attenuated vaccination within 3 months prior to first dose of study drug (e.g. MMR, Yellow Fever, Rotavirus, Smallpox, etc.).'}, 'identificationModule': {'nctId': 'NCT03447769', 'acronym': 'Canopy-A', 'briefTitle': 'Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Double Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Canakinumab Versus Placebo as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II -IIIA and IIIB (T>5cm N2) Completely Resected (R0) Non-small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'CACZ885T2301'}, 'secondaryIdInfos': [{'id': '2017-004011-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'canakinumab', 'description': 'Participants received 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)', 'interventionNames': ['Drug: Canakinumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Canakinumab', 'type': 'DRUG', 'otherNames': ['ACZ885'], 'description': '200 mg of canakinumab administered subcutaneously on day 1 of every 21-day cycle for 18 cycles. Canakinumab solution for injection was provided by Novartis as ready-to-use pre-filled syringes to be administered by study personnel.', 'armGroupLabels': ['canakinumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered subcutaneously on day 1 of every 21-day cycle for 18 cycles. Placebo solution for injection was provided by Novartis as ready-to-use pre-filled syringes to be administered by study personnel.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group .', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Cancer and Blood Specialty Clinic', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304-1207', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System CRLX030A2301', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Sansum Clinic', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '80501', 'city': 'Longmont', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers Denver-Mdtn(Bone&MarrowTransp)', 'geoPoint': {'lat': 40.16721, 'lon': -105.10193}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Medical Specialties Drug Ship - 2', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Affiliates of Ocala', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 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